MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Catalog Number 07028121190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys vitamin b12 immunoassay results for two patient sample from cobas e 801 analyzer serial number (b)(4).Patient 1 initial results were 98.9 pmol/l and 139 pmol/l.On (b)(6) 2019, the repeat result from a siemens analyzer was 275 pmol/l.Patient 2 initial results were 92.3 pmol/l and 95.6 pmol/l.On (b)(6) 2019, the repeat result from a siemens analyzer was 159 pmol/l.The results were reported outside of the laboratory and were questioned by the clinician.

Manufacturer Narrative

The calibration data is acceptable, and the customer¿s qc data is within their ranges.Based on this, a general reagent issue can be excluded.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9224345
• MDR Text Key: 203488842
• Report Number: 1823260-2019-03834
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07028121190
• Device Lot Number: 413014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR